Organization of the health system in Bulgaria - focus on payment and affordability of medicines
DOI:
https://doi.org/10.24959/sphhcj.25.352Keywords:
healthcare costs; measures for cost control; affordability of medicines; access to medicines; co-paymentAbstract
Aim. The aim of the study is retrospective review and analysis of implemented measures for improving access to patients' therapy in Bulgaria.
Materials and methods. The study is based on data from officially published regulations and laws, as well as publications on cost control measures in healthcare and their impact on patients and government spending. Mechanisms of regulatory institutions introduced through laws and regulations are also mentioned in the analysis.
Results and discussion. The actions adopted are divided into several groups in order to examine all aspects of medicines affordability - mechanisms for cost control affecting access to medicines, patients' co-payment, and physical availability of medicines. The external reference pricing, Health technology assessment (HTA), discounts and negotiations, regressive scale for price calculation, generics price cap, budget cap and payback mechanism, therapeutic effect monitoring are used for medicines price setting and control. It was found that despite the decrease in drug prices, there is a noticeable increase in government spending, as well as an increase in household spending. The retail pharmacies established in the country are mainly in the large cities. About 32 municipalities could not provide patients' access to medicines. The financial cost implications are substantial and the burden for patients is increasing.
Conclusion. Efforts in recent years have focused on reducing costs for both patients and the population as a whole. The study found that the introduction of reference pricing (internal and external), health technology assessment, budget constraints, negotiations, and generic drug policies do not contribute to patient access to therapy. Cost control measures implemented at this stage are not as effective as expected. In addition, it was found that household spending on medicines has been increasing in recent years, and all policy measures taken do not contribute to supporting patients financially.
References
Ntais, C., Talias, M. A., Fanourgiakis, J., & Kontodimopoulos, N. (2024). Managing Pharmaceutical Costs in Health Systems: A Review of Affordability, Accessibility and Sustainability Strategies. J. Mark Access Health Policy, 12(4), 403–414. http://doi.org/10.3390/jmahp12040031
Mitkova, Z., Doneva, M., Gerasimov, N., Tachkov, K., Dimitrova, M., Kamusheva, M., & Petrova, G. (2022). Analysis of Healthcare Expenditures in Bulgaria. Healthcare (Basel), 10(2), 274. http://doi.org/10.3390/healthcare10020274
Vogler, S., Haasis, M. A., Zimmermann, N. (2021). Financial burden of medicines for patients: Co-payments and protective measures in European countries. Factsheet prepared for the European Public Health Week 2021. Gesundheit Österreich (GÖG / Austrian National Public Health Institute), Vienna. https://jasmin.goeg.at/id/eprint/1812/1/FactSheet_BurdenCoPayMedicines_bf.pdf
Vogler, S., Dedet, G., & Pedersen, H. B. (2019). Financial Burden of Prescribed Medicines Included in Outpatient Benefits Package Schemes: Comparative Analysis of Co-Payments for Reimbursable Medicines in European Countries. Applied health economics and health policy, 17(6), 803–816. https://doi.org/10.1007/s40258-019-00509-z
Corruption. Reports and documents. (2020). European Union. https://europa.eu/eurobarometer/surveys/detail/2247
Dimova, A., Rohova, M., Koeva, S., Atanasova, E., Koeva-Dimitrova, L., & Kostadinova, T. (2022, December 9). Bulgaria: Health System Summary 2022. WHO Regional Office for Europe on behalf of the European Observatory on Health Systems and Policies. Copenhagen. https://eurohealthobservatory.who.int/publications/i/bulgaria-health-system-summary
Innovative payment models for high-cost innovative medicines. Expert Panel on effective ways of investing in Health (EXPH). (2018). Publications Office of the European Union. https://health.ec.europa.eu/system/files/2019-11/opinion_innovative_medicines_en_0.pdf
Webb, E., Offe, J., & Van Ginneken, E. (2022). Universal Health Coverage in the EU: what do we know (and not know) about gaps in access? Eurohealth, 28(3), 13–17. https://iris.who.int/bitstream/handle/10665/362197/Eurohealth-28-3-13-17-eng.pdf?sequence=1&isAllowed=y
Ferrario, A., Arāja, D., Bochenek, T., Čatić, T., Dankó, D., Dimitrova, M., Fürst, J., Greičiūtė-Kuprijanov, I., Hoxha, I., Jakupi, A., Laidmäe, E., Löblová, O., Mardare, I., Markovic-Pekovic, V., Meshkov, D., Novakovic, T., Petrova, G., Pomorski, M., Tomek, D., . . . Godman, B. (2017). The Implementation of Managed Entry Agreements in Central and Eastern Europe: Findings and Implications. Pharmacoeconomics, 35(12), 1271–1285.
Tachkov, K., Savova, A., Manova, M., Petrova, G. (2023). Tackling reimbursement challenges to fair access to medicines – introduction to the topic. Expert Review of Pharmacoeconomics & Outcomes Research, 23(6), 597–606. https://doi.org/10.1080/14737167.2023.2203384
Garrison, L. P., Towse, A., Briggs, A., De Pouvourville, G., Grueger, J., & Mohr, P. E. (2013). Performance Based Risk-Sharing Arrangements—Good Practices for Design, Implementation, and Evaluation: Report of the ISPOR Good. Practices for Performance-Based Risk-Sharing Arrangements Task Force. Value Health, 16, 703–719.
Mitkova, Z., Manev, I., Tachkov, K., Boyadzhieva, V., Stoilov, N., Doneva, M., & Petrova, G. (2023). How Managed Entry Agreements Influence the Patients’ Affordability to Biological Medicines—Bulgarian Example. Healthcare, 17(11), 2427. https://doi.org/10.3390/healthcare11172427
National Council on Prices and Reimbursement of Medicinal Products. Registers. Republic of Bulgaria. https://ncpr.bg/en/
National Council of Pricing and Reimbursement of Medicinal Products. Ordinance on the Terms, Rules and Procedure for Regulation and Registration of Prices for Medicinal Products. Effective as from 30 April 2013, Amended and Supplemented. (2021, April 28). State Gazette. https://www.ncpr.bg/en/regulations/bulgarian-legislation/regulations.html
On the Conditions, Procedure, Mechanism and Criteria for Payment by the National Health Insurance Fund of Medicinal Products, Medical Devices and Dietary Foods for Special Medical Purposes, Negotiation of Discounts and Application of Mechanisms Ensuring Predictability and Sustainability of the Budget of the NHIF. Ministry of Health. Amended and Supplemented Ordinance № 10 of 2009. (2024). State Gazette, 43 of May.
Bulgaria: Law for the Health Insurance. 22 June 1998. Amended and Supplemented. (2024, May 39). State Gazette. https://www.refworld.org/legal/legislation/natlegbod/1998/en/17872
Manova, M., Mitkova, Z.E., Savova, A., Borisova, A., Peikova, L., Mitkov, J., & Petrova, G. (2023). Impact of generics competition on prices and utilization of antiepileptic medicines in Bulgaria. Journal of Applied Pharmaceutical Science, 13(05), 066–072. https://doi.org/10.7324/JAPS.2023.115004
Mitkova, Z., Dimitrova, M., Doneva, M., Tachkov, K., Kamusheva, M., Marinov, L., Gerasimov, N., Tcharaktchiev, D., & Petrova, G. (2022). Budget cap and pay-back model to control spending on medicines: A case study of Bulgaria. Front Public Health, 10, 1011928. http://doi.org/10.3389/fpubh.2022.1011928
A brief overview of access and efficiency in healthcare. How Bulgaria's healthcare system works for the patient. Institute for market economics, April, 2022. https://www.oecd.org/content/dam/oecd/en/publications/reports/2023/12/bulgaria-country-health-profile-2023_e40050b2/8d90f882-en.pdf
National Health Insurance Fund. General information for the country. https://www.nhif.bg/
Report of public revenue and expenditure in the Republic of Bulgaria. 2021. www.minfin.bg
Mitkova, Z., & Petrova, G. (2021). Analysis of the Household and Health Care System Expenditures in Bulgaria. Front Public Health, 9, 675277. http://doi.org/10.3389/fpubh.2021.675277
Bulgaria: Country health profile 2023. (2023, December 15). OECD. https://www.oecd.org/en/publications/bulgaria-country-health-profile-2023_8d90f882-en.html
Effects of increased reimbursement of medicinal products used for the treatment of ICD codes: I11.0; I11.9; I12.0; I12.9; I13.0; I13.1; I13.2; I20.0; I20.1; I20.8; I20.9; I25.5; I47.1; I48; I50.0; I50.1. National Health Insurance Fund. https://www.nhif.bg/bg/news/747
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2025 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
